Cosmetic AppearanceNCT01446835
Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect
A study testing nelfilcon A contact lens with print and etafilcon A contact lens with print in people with Cosmetic Appearance, run by CIBA VISION at 1 site in Singapore.
Trial summary
The purpose of this study is to compare the cosmetic appearance of two different contact lenses on Asian eyes. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Cosmetic Appearance
- What is being tested?
- nelfilcon A contact lens with print and etafilcon A contact lens with print
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2011to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female between 18 and 30 years of age (inclusive).
- If under 21 years of age, subject must sign informed assent and have written consent of parent or guardian to participate.
- Sign written Informed Consent.
- Chinese, Japanese, or Korean descent.
- Brown eye color.
- Spherical equivalent refractive error of -0.50 diopter (D) and between (-1.50 to -2.50D), (-3.50 to -4.50D) and (-5.50 to -6.50D).
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Eye injury or surgery within twelve weeks prior to enrollment.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in any clinical ophthalmic trial.
- Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the cosmetic appearance of two different contact lenses on Asian eyes.
Read the detailed description
Participants will be asked to evaluate the cosmetic appearance of two different contact lenses worn contralaterally for 20 minutes. No vision or comfort variables will be assessed in this cosmetic appearance and lens fit non-dispensing study.
- Conditions
- Cosmetic Appearance
- Being tested
- nelfilcon A contact lens with print, etafilcon A contact lens with print
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nelfilcon A contact lens with printDevice
Investigational spherical contact lens
etafilcon A contact lens with printDevice
Also called 1-DAY ACUVUE DEFINE Vivid Style
Commercially marketed (Singapore) spherical contact lens
| Study group | Role | What they receive |
|---|---|---|
| nelfilcon A | Experimental | Nelfilcon A printed contact lens randomly assigned to one eye, with etafilcon A printed contact lens assigned to the fellow eye for contralateral wear. Lenses will be worn for 20 minutes. Receives: Device: nelfilcon A contact lens with print |
| etafilcon A | Active comparator | Etafilcon A printed contact lens randomly assigned to one eye, with nelfilcon A printed contact lens assigned to the fellow eye for contralateral wear. Receives: Device: etafilcon A contact lens with print |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic Appearance Preference
Participant will be asked on a questionnaire, "Which lens do you prefer for looking more natural?" Subject will record on the questionnaire, "Left lens," "Right lens," or "No preference."
Measured: After 20 minutes of wear
Secondary outcomes (1)
Lens Centration
Investigator will assess lens centration using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens centration will be graded on a 5-point scale, with 0 being centered and 4 being severe decentration with corneal exposure.
Measured: After insertion and before 20 minutes of wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cosmetic AppearanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- CIBA VISION
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Danny Sim Chek Hoo, B Optom (Hons), Principal investigator, Singapore Polytechnic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446835
- Sponsor's protocol ID
- P-418-C-003
- Status last verified
- Jan 2012
- First submitted
- 3 Oct 2011
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect
- ClinicalTrials.gov ID
- NCT01446835
- Acronym / sponsor ID
- P-418-C-003
- Conditions
- Cosmetic Appearance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the cosmetic appearance of two different contact lenses on Asian eyes.
Detailed description
Participants will be asked to evaluate the cosmetic appearance of two different contact lenses worn contralaterally for 20 minutes. No vision or comfort variables will be assessed in this cosmetic appearance and lens fit non-dispensing study.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nelfilcon A | Experimental | Device: nelfilcon A contact lens with printNelfilcon A printed contact lens randomly assigned to one eye, with etafilcon A printed contact lens assigned to the fellow eye for contralateral wear. Lenses will be worn for 20 minutes. |
| etafilcon A | Active comparator | Device: etafilcon A contact lens with printEtafilcon A printed contact lens randomly assigned to one eye, with nelfilcon A printed contact lens assigned to the fellow eye for contralateral wear. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female between 18 and 30 years of age (inclusive).
- If under 21 years of age, subject must sign informed assent and have written consent of parent or guardian to participate.
- Sign written Informed Consent.
- Chinese, Japanese, or Korean descent.
- Brown eye color.
Key exclusion criteria (6 listed)
- Eye injury or surgery within twelve weeks prior to enrollment.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in any clinical ophthalmic trial.
- Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nelfilcon A contact lens with printInvestigational spherical contact lens | Device | nelfilcon A |
| etafilcon A contact lens with printAlso: 1-DAY ACUVUE DEFINE Vivid StyleCommercially marketed (Singapore) spherical contact lens | Device | etafilcon A |
Primary outcome
Cosmetic Appearance Preference
Time frame: After 20 minutes of wear
Participant will be asked on a questionnaire, "Which lens do you prefer for looking more natural?" Subject will record on the questionnaire, "Left lens," "Right lens," or "No preference."
1 secondary outcome
Lens Centration
Time frame: After insertion and before 20 minutes of wear
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
Related trials for Cosmetic Appearance
Recruiting
Clinical Evaluation of a Multi-functional Beauty Device on Cosmetic Skin Outcomes
Skin Appearance, Skin Texture
Recruiting
Observational Assessment of Skin Appearance Changes During PRX S Cosmetic Treatment in Participants With Acne-Prone Skin
Acne-prone Skin, Skin Disease
RecruitingPhase 4
Study to Assess Participant Satisfaction After Jawline and Neck Treatment
Jawline and Neck Appearance
Not yet recruiting
Evaluation of SPM™ Topical Cosmetic Application on Skin Appearance, Hydration, and Barrier Support in Healthy Adults
Healthy Skin, Skin Hydration
Active, not recruitingObservational study
AI-Powered Beauty Perceptions and Social Media Awareness Regarding Appearance on Social Appearance Anxiety in Patients Undergoing Cosmetic Surgery
Aesthetic Perception, Nursing Care
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danny Sim Chek Hoo, B Optom (Hons) principal investigator
Singapore Polytechnic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nelfilcon A contact lens with print and etafilcon A contact lens with print in people with Cosmetic Appearance, run by CIBA VISION at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cosmetic Appearance Preference (time frame: After 20 minutes of wear). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2012.